Bronchoscopic Navigation Robot-guided Dye Marking-assisted Thoracoscopic Pulmonary Nodule Resection

NCT06821451 | Recruiting

• 1 other identifier: RTS-025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

With the widespread use of low-dose spiral CT screening for the lungs, an increasing number of small nodules are being detected, and surgical resection is the preferred method for clinical intervention of pulmonary nodules. Staining localization can assist surgeons in accurately locating pulmonary nodules during surgery, achieving complete resection of the nodules while minimizing the resection area, thereby optimizing surgical outcomes. The study will include individuals with pulmonary nodules detected by CT scans who require color localization assistance for thoracoscopic pulmonary nodule resection, randomly divided into two groups: one group will receive bronchoscopic navigation-assisted staining localization, while the other group will receive staining localization guided by an electromagnetic navigation system. The primary outcome is to evaluate the success rate of staining localization between the two groups. This study aims to assess, through a prospective, single-center, randomized controlled clinical trial, whether the success rate of staining localization guided by bronchoscopic navigation robots (experimental group) is not lower than that of staining localization guided by the electromagnetic navigation system (control group), while potentially offering advantages such as a shorter learning curve, ease of operation, and reduced surgical time. This will provide a new efficient and safe method for the localization of pulmonary nodules clinically, greatly supporting accurate treatment of pulmonary nodules.

Conditions

Lung Nodules

Outcome Measures

Primary Outcomes (1)

• Success rate of staining localization

  The success rate of staining localization is defined as the number of cases with successful staining divided by the total number of cases undergoing surgery (100%). Successful staining is defined as the staining marker being clearly visible during thoracoscopy, with the staining point being less than 1 centimeter away from the nodule on the pleural projection.

  During surgical procedure

Secondary Outcomes (4)

• Re-excision rate

  During surgical procedure

• Surgery duration

  During surgical procedure

• Length of hospital stay

  From hospital admission to discharge, assessed daily throughout the hospitalization period (expected range: 1 to 30 days)

• Incidence of complications related to staining localization

  During surgical procedure

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Preoperative CT data creates a 3D image of the lung anatomy to plan the navigation path. The surgeon controls the robotic arm in real-time to reach staining marker points for pulmonary nodule localization. After placing the staining catheter in the working channel, 1 ml of indocyanine green is injected at the site. Then the patient is positioned laterally for video-assisted thoracoscopic surgery for nodule resection, initially focusing on sub-lobar resection. More extensive resection is determined based on intraoperative frozen section results.

Device: Bronchoscopic navigation robot

Control group

SHAM COMPARATOR

Based on preoperative CT data, a three-dimensional image of the virtual bronchi is created to plan the navigation path, and manual registration is completed by selecting registration points using a conventional bronchoscope. After registration, the target position is reached under the guidance of the magnetic navigation positioning system, and when the positioning sensor indicates that it has arrived at the staining marker point, a staining catheter is inserted through the working channel to inject 1 ml of indocyanine green at the marker site, followed by thoracoscopic resection of the pulmonary nodule.

Device: Conventional electromagnetic navigation bronchoscope

Interventions

Bronchoscopic navigation robot DEVICE

Preoperative CT data creates a 3D image of the lung anatomy to plan the navigation path. The surgeon controls the robotic arm in real-time to reach staining marker points for pulmonary nodule localization. After placing the staining catheter in the working channel, 1 ml of indocyanine green is injected at the site. Then the patient is positioned laterally for video-assisted thoracoscopic surgery for nodule resection, initially focusing on sub-lobar resection. More extensive resection is determined based on intraoperative frozen section results.

Also known as: bronchoscopic navigation positioning device, Robotic-assisted bronchoscopy, robotic-assisted bronchoscopy system

Treatment group

Conventional electromagnetic navigation bronchoscope DEVICE

Based on preoperative CT data, a three-dimensional image of the virtual bronchi is created to plan the navigation path, and manual registration is completed by selecting registration points using a conventional electromagnetic bronchoscope. After registration, the target position is reached under the guidance of the magnetic navigation positioning system, and when the positioning sensor indicates that it has arrived at the staining marker point, a staining catheter is inserted through the working channel to inject 1 ml of indocyanine green at the marker site, followed by thoracoscopic resection of the pulmonary nodule.

Also known as: ENB, Electromagnetic navigation bronchoscopy system

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years, regardless of gender;
• Peripheral pulmonary nodules, planned for single lesion non-anatomical sublobar resection via thoracoscopic assistance after preoperative discussion;
• Preoperative assessment indicates that the pulmonary nodules cannot be localized through visual inspection or palpation;
• Patients are able to understand the purpose of the trial, have good compliance with examinations and follow-ups, and voluntarily participate in the clinical trial by signing an informed consent form.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from this study:
• \- Surgical contraindications that do not meet surgical tolerance standards: fulfilling one major criterion and/or two or more minor criteria.
• Major criterion: Forced expiratory volume in 1 second (FEV1) or carbon monoxide diffusion capacity (DLCO) ≤ 50%.
• Minor criterion: (1) FEV1 or DLCO 51%-60%; (2) Age ≥ 75 years; (3) Pulmonary hypertension \> 40 mmHg (1 mmHg = 0.133 kPa); (4) Left ventricular ejection fraction (LVEF) ≤ 40%; (5) Arterial blood partial pressure of oxygen (PaO2) \< 55 mmHg or arterial blood oxygen saturation (SpO2) ≤ 88% with arterial blood partial pressure of carbon dioxide (PaCO2) \> 45 mmHg.
• Contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe hypertension and arrhythmias; uncorrectable bleeding tendencies (such as severe coagulopathy, uremia, and severe pulmonary hypertension, etc.); severe superior vena cava syndrome; suspected aortic aneurysm; multiple pulmonary bullae; extremely poor overall condition;
• Female patients who are breastfeeding, pregnant, or trying to conceive;
• Patients with electromagnetic active implantable devices;
• Participants allergic to indocyanine green or anesthetics; or with a history of multiple severe allergies or hereditary allergies;
• Participation in drug clinical trials in the past 3 months, or currently participating, or participation in other medical device clinical trials within the past 30 days;
• Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Central Study Contacts

Hecheng Li

CONTACT

021-021-64370045; lihecheng2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 12, 2025
• Study Start: February 10, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: With publication
• Access Criteria: Interested investigators will be required to submit a formal letter of intent outlining research aims, rationale, and approach. Furthermore, documentation of local IRB approval, including a description of type of review, should be submitted with the data request.

Locations

CN (1)